FindTrial
Sign In

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL GROUP STUDY TO DEMONSTRATE THE EFFICACY AND ASSESS THE SAFETY OF CD07805/47 GEL 0.5% APPLIED TOPICALLY ONCE DAILY IN SUBJECTS WITH MODERATE TO SEVERE FACIAL ERYTHEMA OF ROSACEA

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, VEHICLE-CONTROLLED, PARALLEL GROUP STUDY TO DEMONSTRATE THE EFFICACY AND ASSESS THE SAFETY OF CD07805/47 GEL 0.5% APPLIED TOPICALLY ONCE DAILY IN SUBJECTS WITH MODERATE TO SEVERE FACIAL ERYTHEMA OF ROSACEA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-001044-22-SE
Enrollment
140
Registered
2012-06-27
Start date
2012-08-15
Completion date
Unknown
Last updated
2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rosacea MedDRA version: 14.1 Level: PT Classification code 10039218 Term: Rosacea System Organ Class: 10040785 - Skin and subcutaneous tissue disorders

Interventions

Product Code: CD07805/47 Pharmaceutical Form: Gel INN or Proposed INN: BRIMONIDINE TARTRATE CAS Number: 70359-46-5 Current Sponsor code: CD07805/47 Other descriptive name: COL-118 Concentration unit:

Sponsors

Galderma R&D SNC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Male or female, who is at least 18 years of age or older at screening visit. - Clinical diagnosis of facial rosacea. - A Clinician’s Erythema Assessment (CEA) score of >3 at Screening and at Pre-dose (T0) on Baseline/Day 1 - A Patient Self Assessment (PSA) score of >3 at Screening and at Pre-dose (T0) on Baseline/Day 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: - More than 20 facial inflammatory lesions of rosacea - Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that share clinical features with rosacea such as peri oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.

Design outcomes

Primary

MeasureTime frame
Main Objective: To demonstrate efficacy and to assess the safety of CD07805/47 gel 0.5%, applied topically once daily for 29 days versus vehicle control, in subjects with moderate to severe facial erythema of rosacea. ;Secondary Objective: ;Primary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: 1-grade Composite Success at Hours 3, 5, 7, and 9 after Pre-dose (T0), first on Day 29/ET, then on Day 15 and lastly Day 1: 1-grade Composite Success is defined as 1 grade improvement on both CEA and PSA at each time point.—

Secondary

MeasureTime frame
Secondary end point(s): Efficacy;Timepoint(s) of evaluation of this end point: 30 Minute Effect, defined as 1 grade composite improvement on both CEA and PSA at 30 minutes after Pre-dose (T0) on Day 1.—

Countries

Russian Federation, Sweden

Contacts

Public ContactCTA Coordinator

Galderma R&D SNC

cta.coordinator@galderma.com+33(0)493-95-70-85

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026